PlainRecalls

Rugby Children's Pain & Fever Concentrated Drops Recalled Due To Failure to Meet Child-Resistant Closure Requirement

Reported: June 23, 2011 Initiated: June 23, 2011 #11258 About 898,000 units

Altaire Pharmaceuticals, Inc., of Aquebogue, N.Y issued this CPSC recall on June 23, 2011. Classified as Moderate severity. Approximately About 898,000 units are affected. The recall was issued because: This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Pois…. This recall notice is sourced from official CPSC enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This CPSC action (record #11258) was formally reported on June 23, 2011. It is classified under Moderate severity, with a current status of Active. Altaire Pharmaceuticals, Inc., of Aquebogue, N.Y is listed as the recalling firm. Federal records indicate About 898,000 units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Poison Prevention Packaging Act. Although the original bottle has child-resistant packaging, a separate … Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. The remedy documented by the agency is: Consumers should immediately store this product with the child-resistant closure in place and keep it out of the reach of children. To arrange for a free replacement dropper, contact Altaire Pharmace… — consumers holding this product should act on that instruction rather than relying on general guidance.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 1 were also issued by CPSC. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 15 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

About 898,000

Related Recalls

6

1 from same agency

Product Description

The recall involves Rugby Children's Pain & Fever Concentrated Drops (Acetaminophen Drops) in a 1/2 fl. oz. (15 ml) bottle size. The UPC code 305361936723 can be found with the bar code at the bottom of the box. The affected lot numbers are: 09002 09379 10272 10368 10487 09131 09394 10273 10406 11058 09215 10154 10366 10433 The lot numbers can be found stamped into the bottom of the carton with the expiration date and above the label on the bottle printed in black.

Reason for Recall

This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Poison Prevention Packaging Act. Although the original bottle has child-resistant packaging, a separate dropper unit provided for dispensing the drug to children does not. When in use, a child can access the medicine, posing serious health problems or death if more than the recommended dosage is consumed.

Remedy

Consumers should immediately store this product with the child-resistant closure in place and keep it out of the reach of children. To arrange for a free replacement dropper, contact Altaire Pharmaceuticals at (800) 258-2471 9 a.m. to 5 p.m. ET Monday through Friday.

Recall Profile

Structured summary of the CPSC recall record
Attribute Value
Agency U.S. Consumer Product Safety Commission
Severity class Moderate
Status Active
Recall number 11258
Date reported June 23, 2011
Date initiated June 23, 2011
Recalling firm Altaire Pharmaceuticals, Inc., of Aquebogue, N.Y
Units affected About 898,000
Distribution Not disclosed

Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.

Scale of Impact

About 898,000 units affected — multi-state distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Consumer Product Safety Commission filings.

Frequently Asked Questions

What product was recalled?
The recall involves Rugby Children's Pain & Fever Concentrated Drops (Acetaminophen Drops) in a 1/2 fl. oz. (15 ml) bottle size. The UPC code 305361936723 can be found with the bar code at the bottom of the box. The affected lot numbers are: 09002 09379 10272 10368 10487 09131 09394 10273 10406 11058 09215 10154 10366 10433 The lot numbers can be found stamped into the bottom of the carton with the expiration date and above the label on the bottle printed in black.. Recalled by Altaire Pharmaceuticals, Inc., of Aquebogue, N.Y. Units affected: About 898,000.
Why was this product recalled?
This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Poison Prevention Packaging Act. Although the original bottle has child-resistant packaging, a separate dropper unit provided for dispensing the drug to children does not. When in use, a child can access the medicine, posing serious health problems or death if more than the recommended dosage is consumed.
What should consumers do?
Consumers should immediately store this product with the child-resistant closure in place and keep it out of the reach of children. To arrange for a free replacement dropper, contact Altaire Pharmaceuticals at (800) 258-2471 9 a.m. to 5 p.m. ET Monday through Friday.
Which agency issued this recall?
This recall was issued by the CPSC on June 23, 2011. Severity: Moderate. Recall number: 11258.
How do I check if my product is affected by a recall?
Check the product description and recall number (11258) against your product. Visit the official CPSC website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
How do I report an injury from a recalled product?
Report injuries to the issuing agency: CPSC at SaferProducts.gov, NHTSA at nhtsa.gov/report-a-safety-problem, or FDA via MedWatch. Document the product (photos, model/serial numbers, purchase receipts) and seek medical attention. Injury reports help agencies track hazard patterns and may strengthen enforcement actions.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, … →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).