CriticalClass ITerminated

FDA Drug recall · Reported May 2, 2018

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

Q: Which agency issued this recall?

This recall was issued by the FDA Drug on May 2, 2018. Severity: Critical. Recall number: D-0697-2018.

Q: Where was the recalled product distributed?

Distribution: Nationwide in the USA.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because t…

Recall #: D-0697-2018
Affected scope: 188,631 units
Initiated: March 15, 2018

Compiled from official public sources by the publisher. · Updated September 2026

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Bayer HealthCare Pharmaceuticals, Inc. recalled All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) a… - a critical-severity action.

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) a… was recalled by Bayer HealthCare Pharmaceuticals, Inc. in May 2, 2018. Reason: Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo …. Check the official notice for the remedy. Verify recall #D-0697-2018 with the FDA Drug before acting.

The recall

Bayer HealthCare Pharmaceuticals, Inc. issued this critical-severity FDA Drug recall-Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo ….

Critical
severity level: 189K units
affected scope: Class I
classification: May 2, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0697-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

Reason for recall

Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	D-0697-2018
Date reported	May 2, 2018
Date initiated	March 15, 2018
Recalling firm	Bayer HealthCare Pharmaceuticals, Inc.
Firm location	Whippany, NJ
Affected scope	188,631 units
Distribution	Nationwide in the USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

188,631 units 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. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0697-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 2, 2018. Severity: Critical. Recall number: D-0697-2018.

Where was the recalled product distributed? ▼

Distribution: Nationwide in the USA.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported May 2, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026