CLASS III Drug recall · Reported 7 Sep 2022 · FDA Enforcement Report
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets recalled
LNK International is recalling Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg blisters per, distributed nationwide in the US. The recall was initiated on 4 Aug 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1472-2022
- FDA event ID
- 90708
- Recalling firm
- LNK International, Hauppauge, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Aug 2022
- FDA classified
- 30 Aug 2022
- Reported
- 7 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 4 Aug 2022 | Recall initiated by company | |
| 30 Aug 2022 | Classified by FDA | +26 days |
| 7 Sep 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Product as listed by the FDA
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
Where it was distributed
Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.
Stores named: CVS
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Which lots are affected?
P121512, exp. date 08/2023; P122015, exp. date 09/2023; P122712, exp. date 11/2023; P123090, exp. date 12/2023; P123170, exp. date 12/2023; P124325, exp. date 03/2024; P124664, exp. date 03/2024; P125165, exp. date 05/2024; P125576, exp. date 06/2024; P125577, exp. date 06/2024; P127089, exp. date 10/2024; P127090, exp. date 10/2024; P127386, exp. date 11/2024; P128572, exp. date 01/2025; P128383, exp. date 01/2025; P129536, exp. date 04/2025
Where was it sold?
Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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